Industry News

News from the 55th Annual Scientific Session of the American College of Cardiology Meeting

Held March 11-14, 2006 in Atlanta, Georgia
Held March 11-14, 2006 in Atlanta, Georgia

Abbott Reports Positive Results From First Human Clinical Trial Featuring ZoMaxx Drug-Eluting Coronary Stent

Abbott announced the first clinical results for its investigational ZoMaxx Drug-Eluting Coronary Stent System. Data from ZOMAXX IVUS, a 40-patient, single-arm, clinical, angiographic and intravascular ultrasound (IVUS) trial sponsored by Abbott, demonstrated 100 percent procedural success, no major adverse cardiac events and minimal late lumen loss(vessel diameter loss) during the four-month follow-up period. The objective of the study was to evaluate the safety and performance of ZoMaxx for the treatment of coronary artery disease. These data were presented at the 2006 American College of Cardiology Scientific Session in Atlanta. The results of the ZOMAXX IVUS study are encouraging as they demonstrated that controlled release of zotarolimus minimized neointimal proliferation over the first four months following stent implantation, said Alexandre Abizaid, MD, PhD, Instituto Dante Pazzannese, Sao Paulo, Brazil, and principal investigator of the ZOMAXX IVUS clinical trial. The ZoMaxx stent is a highly deliverable device that is easy to see under x-ray. ZOMAXX IVUS was a clinical, angiographic and intravascular ultrasound (IVUS) trial conducted in 40 patients with a mean age of 59 years (± 9). Eighty percent of patients had hyperlipidemia (high cholesterol), 40 percent had diabetes, and 40 percent had a prior heart attack. The mean lesion length stented was 14.4 mm (± 3.3). Before treatment with a ZoMaxx stent, percent diameter stenosis (DS) was 70% (± 10). Directly after treatment with ZoMaxx, percent diameter stenosis improved to 5.1 percent (± 5.3) inside the stent (in-stent) and 19 percent (± 7) in-segment, or within the stent plus 5 mm on either side of it. Late lumen loss, a measure of the change in vessel diameter between the time immediately following stent placement and (in the case of ZOMAXX IVUS) at four months, was 0.20 mm (± 0.35) in-stent and 0.17 mm (± 0.35) in-segment. In-stent net volume obstruction was 6.5 percent (± 6.2). The ZoMaxx stent was delivered with 100 percent success, and no major adverse cardiac events (MACE) occurred during the procedure or during the four months of follow up. The ZoMaxx Drug-Eluting Coronary Stent System features proprietary application of a biologically inert coating called Pharmacoat, intended to enable steady drug elution over time, and proprietary application of Abbott’s patent-protected immunosuppressant drug, zotarolimus, which has been studied for the reduction of vessel renarrowing. The system’s TriMaxx stent platform is made of stainless steel and tantalum to enable optimal visibility under x-ray, with extremely thin struts and an ultra-low crossing profile. Pharmacoat is licensed to Abbott from Biocompatibles International plc.

New Study Furthers Understanding of the Role of Dual Antiplatelet Therapy in the Prevention of Atherothrombotic Events, Including Heart Attack, Stroke or Cardiovascular Death in Broad Population

Certain subgroups may benefit from dual therapy, for others it should be avoided

Results from the CHARISMA (Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance) trial showed that the combination of the antiplatelet agents clopidogrel and aspirin did not demonstrate a statistically significant reduction in the risk of heart attack, stroke or cardiovascular death compared to placebo and aspirin in a broad population of patients with either established atherothrombotic disease or multiple risk factors for atherothrombotic events. Analysis of the two main patient enrollment subgroups revealed different responses to clopidogrel and aspirin therapy. In patients with established atherothrombotic disease (also referred to as secondary prevention), the CHARISMA findings demonstrated clopidogrel in addition to aspirin and other standard therapy reduced the relative risk of a recurrent heart attack (myocardial infarction or MI), stroke or cardiovascular death by a statistically significant 12.5 percent (p = 0.046) compared to patients receiving placebo and aspirin. These patients accounted for nearly 80 percent (n =12,153) of the total CHARISMA study population. Patients with multiple risk factors but no clearly established vascular disease did not benefit from the addition of clopidogrel to aspirin (20 percent relative risk increase, p = 0.22). These patients represented approximately 20 percent (n = 3,284) of the overall study population. In this patient subgroup, there was an excess in cardiovascular mortality as well as a non-statistically significant increase in bleeding observed in patients treated with clopidogrel and aspirin. Results of the CHARISMA trial were presented at the 55th Annual Scientific Session of the American College of Cardiology (ACC) meeting in Atlanta, Georgia. The CHARISMA trial was coordinated by the Cleveland Clinic Cardiovascular Coordinating Center group. The primary investigator of the CHARISMA trial was Dr. Deepak Bhatt, and the study was chaired by Professor Eric Topol. The CHARISMA trial was supported by grants from Sanofi-Aventis and Bristol-Myers Squibb Company.

Targeted Renal Therapy May Help to Prevent Kidney Failure

Targeted renal therapy (TRT) may help to prevent contrast-induced nephropathy (CIN) in at-risk patients, according to preliminary results of a multicenter trial presented at the 55th Annual Scientific Session of the American College of Cardiology (ACC). TRT is the delivery of certain medications and other therapeutic agents directly to the kidneys via the renal arteries. CIN can ultimately result in renal failure with need for dialysis, and is associated with increased hospital stays and increased mortality within 6 to 24 months, said Mauricio G. Cohen, MD, associate director of the cardiac catheterization laboratory and assistant professor of medicine at the University of North Carolina, Chapel Hill. Dr. Cohen presented preliminary data on 112 patients enrolled in the Benephit System Renal Infusion Therapy (Be-RITe!) Registry, an observational study conducted at seven U.S. and one European medical centers. The registry is a retrospective, observational review of safety, real-world usage patterns, device performance characteristics and clinical outcomes following TRT with FlowMedica’s Benephit Infusion Systems, which were cleared for the infusion of physician-specified agents in the peripheral vasculature including, but not limited to, the renal arteries. The Benephit Infusion Systems have not received clearance to treat contrast-induced nephropathy or any other condition. Patients in the study reported at ACC were treated with TRT during a variety of endovascular procedures using contrast media, including diagnostic angiography, and interventional treatments for coronary or peripheral arteries. Patients who suffer from diabetes, heart failure or impaired kidney function or are of advanced age are at particularly high risk for CIN; having more than one of these conditions adds to the patient’s risk. CIN is estimated to occur in up to 30 percent of patients who may have risk factors. The patients in our study were at very high risk, with some having three or more risk factors, yet only approximately 10 percent developed CIN, Dr. Cohen said. Although these results are preliminary, TRT appears to be a promising new approach that may avoid kidney dysfunction in patients at risk. Key findings presented by Dr. Cohen at the ACC meeting include: There were only 4 reported minor complications, none of which had lasting patient impact. The renal arteries were accessed bilaterally within 2 minutes with use of minimum amount of dye in 95 percent of patients despite anatomic variations and significant vascular disease. Only 10 percent of patients at very high risk of CIN developed the condition, an estimated 65 percent reduction in relative risk when compared to the predicted CIN incidence in the same population using a validated, published model. A number of strategies have been attempted to prevent CIN in at-risk patients, including administering medications and other therapeutic agents through systemic intravenous (IV) infusion. Systemic infusion of certain agents can cause serious side effects such as hypotension, the lowering of blood pressure. In addition, researchers believe that with systemic infusion, the amount of medication that reaches the kidneys often does not attain sufficient levels to have a therapeutic effect and, therefore, the treatment may not be effective, and can sometimes be harmful, as hypotension increases the risk of CIN. Physician-specified medications delivered intra-renally via TRT in the patients studied included fenoldopam (83.3 percent of cases), sodium bicarbonate (10.2 percent) and alprostadil (6.5 percent).The FlowMedica Benephit® CV and Benephit® PV Infusion Systems used in the study can simultaneously infuse medications and other therapeutic agents into both renal arteries using a single intravascular catheter. The Benephit CV Infusion System is being used clinically as a means to deliver TRT in patients undergoing interventional and diagnostic cardiovascular procedures.

Excellent In-Stent Restenosis Clinical Trial Results Reported for Taxus Stent System

Boston Scientific Corporation announced nine-month data from its TAXUS V ISR (in-stent restenosis) clinical trial. The results demonstrated that patients treated for in-stent restenosis with the Taxus® Express2 paclitaxel-eluting stent system achieved superior outcomes compared to those patients treated with radiation-based brachytherapy. The company made the announcement at the i2 Summit held in conjunction with the annual American College of Cardiology Scientific Session in Atlanta. The results of the drug-eluting stent arm are very impressive given the difficult challenges that restenotic lesions present, said Gregg W. Stone, MD, Professor of Medicine, Columbia University Medical Center in New York and the trial's Principal Investigator. The TAXUS V ISR trial clearly demonstrated that patients with bare-metal stent restenosis had better outcomes when treated with Taxus stents as compared to coronary radiation. The study met its primary endpoint of improved nine-month target vessel revascularization (TVR), which was significantly lower in the Taxus stent group (10.5 percent), as compared to the control group (17.5 percent). The study demonstrated a nine-month target lesion revascularization (TLR) rate of 6.3 percent in the Taxus stent group, as compared to 13.9 for the control group. The study demonstrated an 11.5 percent rate of Major Adverse Cardiac Events (MACE) for the Taxus stent group, as compared to 20.1 percent rate for the control group. TAXUS V ISR is a prospective, randomized, open-label, controlled study of 396 patients at 37 sites in the United States designed to assess the Taxus stent slow-release formulation paclitaxel-eluting coronary stent system in reducing in-stent restenosis (the regrowth of diseased tissue into a previously stented artery) versus intracoronary brachytherapy (radiation delivered directly to the lesion). An additional 25 patients were enrolled in a registry arm. Clinical follow-up included more than 95 percent of the patients enrolled at nine months.

Gene Therapy May Provide Hope for Patients at High Risk of Amputation

A new randomized study presented at the American College of Cardiology’s 55th Annual Scientific Session investigates an innovative treatment for critical limb ischemia, or lack of arterial blood supply and oxygen to the legs, using a therapeutic approach to generate new blood vessels. The TALISMAN (Therapeutic Angiogenesis Leg Ischemia Study for the Management of Arteriopathy and Non-healing ulcers) 201 study examined 107 patients with CLI and compared the results of patients who received either placebo or an intramuscular administration of a novel gene therapy (NV1FGF). NV1FGF is a DNA plasmid which fosters the formation of new blood vessels. This is the first double-blind, placebo-controlled study in CLI subjects who are not eligible for revascularization aiming to decrease the risk of amputation. Despite no improvement on wound healing, data shows that this new treatment significantly reduced the risk of amputation, and may potentially lead to lower mortality rates in patients. In this critically ill population, no difference was observed in the incidence of adverse events between the study drug and placebo. Patients suffering from critical limb ischemia experience an increased danger of amputation and death, said Dr. Sigrid Nikol, MD, University Hospital of Munster in Germany and lead author of the study. Evaluating promising new treatment options is the optimal way to ensure these patients are given the best prognosis possible while maintaining their quality of life. NV1FGF will be further evaluated in phase III in CLI patients with the objective of reduction of amputation and death.

ECG Transmission from Ambulance Cuts Time to Direct Clot Removal

When emergency medical technicians (EMTs) wirelessly transmit eletrocardiograms (ECG) directly to a cardiologist’s hand-held device, heart attack patients can potentially receive direct clot removal in half the usual time, according to cardiologists at Duke University Medical Center and NorthEast Medical Center, Concord, NC. While the American College of Cardiology (ACC) and the American Heart Association recommend that patients have their arteries opened directly within 90 minutes of arriving at the hospital, the NorthEast Medical Center team was able to cut that time to 50 minutes. The national average door-to-reperfusion time is about 100 minutes, the researchers said. The results of the pilot project were presented March 13, 2006, by Duke Clinical Research Institute cardiology fellow George Adams, MD, during the 55th annual scientific sessions of the ACC in Atlanta. His study is one of five finalists for an ACC Young Investigator Award. The team achieved this significant time savings by directly linking EMTs with cardiologists and bypassing the hospital’s emergency department for the small proportion of those patients with chest pain whose ECG is distinctly diagnostic. In the current study, specially trained EMTs transmitted ECG tracings electronically from the scene or in the ambulance to an on-call cardiologist’s personal digital assistant (PDA). The cardiologist on spotting the definitive signs of a heart attack could mobilize the catheterization laboratory while the patient was en route to the hospital. While the time savings achieved in the current pilot project are significant, the researchers point out that the results will need to replicated in more diverse settings. In the current project, NorthEast is staffed by a small number of interventional cardiologists at one hospital with one ambulance service. Duke researchers are currently organizing a 12-site study across the U.S. in larger and smaller cities with different sized hospitals and ambulance services. We found that the pre-hospital wireless transmission of an ECG directly to a cardiologist’s hand-device significantly reduced the time from emergency room door to reperfusion, Adams said. When the cardiologist can directly see an ECG, it clarifies the decision to mobilize all the personnel necessary for the cath lab to be ready to go when the patient arrives. In the final two years of the four-year pilot project, the team enrolled patients with a suspected STEMI who were taken to NorthEast Medical Center. During the intervention phase of trial, the team enrolled 101 self-transported patients, and 24 ambulance patients where the wireless ECG transmission was successful, and 19 patients for whom the wireless transmission was unsuccessful. The median door-to-reperfusion time for those with a successful transmission was 50 minutes, significantly faster than the 96 minutes for those who transported themselves and the 78 minutes for those whose transmission failed, Adams said. Key to the success of the project, the researchers said, is the training of the EMTs. Currently, almost all ambulance services are equipped to perform an ECG at the scene or in the ambulance. However, for any such project to be successful, the researchers said, an EMT needs to be able to spot tell-tale abnormalities, since only about five percent of patients experiencing chest pains need an immediate catheterization. Wireless ECG transmission gets at the ‘heart’ of the problem, which is communication, said Duke cardiologist Galen Wagner, MD, senior member of the research team. We have ability to transport patients and we are good at clearing clots from arteries the challenge is to remove the barriers in-between. Also importantly, said the researchers, the findings add further evidence that patients or families should always call for an ambulance instead of driving themselves to a hospital if a heart attack is suspected. Interestingly, as the project became known to Cabarrus County residents over the four-year period, the researchers noticed a decline in the number of potential heart attack patients transporting themselves to the hospital. While the upcoming trial will test wireless transmission capabilities in a number of different settings, it will also study the effects of shortening the door-to-reperfusion time on mortality and heart muscle salvage. It is estimated that more than 500,000 Americans will come to a hospital with an STEMI. The pilot project was supported by the William T. Morris Foundation, NY, the Duke Endowment, Charlotte, NC, and Welch Allyn, Skaneateles Falls, NY, which provided some of the equipment. The investigators have no financial interest in Welch Allyn.

New Data Suggest Differences in Clinical Performance Between the Cypher® Stent and the Taxus® Stent in Long Complex Lesions

Data from a multi-center, prospective randomized controlled clinical trial suggests that the Cypher® Sirolimus-eluting Coronary Stent outperformed the Taxus® Stent in procedures involving long coronary lesions. The results from the LONG DES-II Study were presented at the American College of Cardiology Conference Annual Scientific Session. The LONG DES-II Study (percutaneous treatment of long native coronary lesions with Drug-Eluting Stents II) was designed to compare the angiographic in-segment binary restenosis rate of Cypher Stent vs. the Taxus Stent at six months. The study was conducted across five medical centers in Korea and included 500 patients (250 in the Cypher Stent arm and 250 in the Taxus Stent arm). Lesion length needed to be > 25 mm. It is estimated that long lesions such as these comprise approximately 20 percent of cases treated by interventional cardiologists today. In this study, the patients received a mean total stent length of about 41 mm. Patients receiving the Cypher Stent had significantly less in-stent late loss than patients treated with the Taxus Stent (0.05 ± 0.22 loss index for the Cypher Stent vs. 0.25 ± 0.35 loss index for the Taxus Stent; p Guidant Announces Updated and Positive Results of Real-World Carotid Artery Stenting Study

Results from 2,500 Patients Suggest Therapy Can Be Performed Safely by Broad Group of Physicians

Guidant Corp. announced updated results of 2,500 patients enrolled in its post approval study of carotid artery stenting, called CAPTURE (Carotid Acculink/Accunet Post Approval Trial to Uncover Rare Events). Results were presented during the Late Breaking Registry Session at the American College of Cardiology meeting in Atlanta by William A. Gray, MD, FACC, from the Columbia University Medical Center in New York. CAPTURE is an FDA-required post-approval study utilizing Guidant’s carotid stent and embolic protection system. Key objectives of CAPTURE are to determine whether carotid artery stenting can be performed safely in real-world clinical settings with physicians of varying levels of experience and to evaluate the effectiveness of Guidant’s training program. The results of the study are consistent with and provide confirmation of positive earlier CAPTURE data presented at the Transcatheter Cardiovascular Therapeutics meeting in October 2005. The study continues to suggest that carotid artery stenting in high surgical risk patients can be performed safely by physicians of different experience levels. The primary endpoint of 30-day death, stroke and myocardial infarction is 5.7 percent. The rate of events leading to significant disability or death (30-day major stroke and death) is 2.5 percent. "The large enrollment and excellent results of CAPTURE show that carotid artery stenting has truly arrived as the treatment for high-surgical risk patients with carotid artery disease at risk of stroke, said Dr. Gray. This landmark U.S. trial is the largest and most rigorous real-world study of carotid stenting with independent neurologic follow up and stroke event adjudication. The results demonstrate that with proper experience levels and device training, carotid stenting can be performed with exemplary results by a variety of physicians in community hospital settings. Results are based on a cohort of 2,500 patients treated with Guidant’s FDA-approved RX Acculink Carotid Stent System and RX Accunet Embolic Protection System, which are indicated for high surgical risk patients. Patients in CAPTURE were treated by 315 physicians, including interventional cardiologists, interventional radiologists, interventional neuroradiologists, vascular surgeons and neurosurgeons, at 137 hospitals in the United States. CAPTURE has enrolled more than 3,700 patients to date and continues to enroll.

STENT Registry Safety Data Favors TAXUS® Over Cypher® in the Most Complex Diabetic Patients

Complex insulin-treated diabetic population shows numerical trend toward improved MACE outcomes with TAXUS versus Cypher

The independent, multi-center STENT registry is the largest prospective, comparative real world drug-eluting stent study ever reported. The study included follow-up on 5,566 patients at eight coronary centers in the United States who received either a Taxus® Express2 paclitaxel-eluting coronary stent system or a Cypher® Stent system, including 1,182 diabetic patients, nearly 500 of whom were insulin-treated diabetics. Among insulin-treated diabetics, the results demonstrated a numerical trend toward improved survival and lower overall Major Adverse Cardiac Events (MACE) rate for patients who received a Taxus stent system versus those who received a Cypher stent system. The results were presented at the American College of Cardiology’s (ACC) inaugural Innovation in Intervention: The i2 Summit in Atlanta. Among the study’s diabetic patients, the Taxus stent system was used in more complex lesions. The Taxus patients had a slightly higher ACC risk score, smaller vessels and longer lesions than Cypher patients. Despite the higher complexity of the Taxus patients, the results favored the Taxus stent system over the Cypher stent system in each of the study's MACE categories for insulin-treated diabetics. The MACE rate was a composite of death (2.1 percent for Taxus versus 5.7 percent for Cypher), myocardial infarction (MI, or heart attack) (1.3 percent for Taxus versus 1.9 percent for Cypher), and target vessel revascularization (TVR) (3.4 percent for Taxus versus 4.2 percent for Cypher). The overall MACE rate also trended in favor of Taxus (6.0 percent versus 10.7 percent for Cypher). In insulin-treated diabetics there is a slight separation in outcomes favoring the Taxus stent system, although this did not reach statistical significance, said Charles Simonton, MD, chairman of the executive steering committee for the STENT registry. We plan continued enrollment to further investigate this apparent difference in outcomes. STENT (Strategic Transcatheter Evaluation of New Therapies) is the first U.S., multi-center, prospective registry initiated to evaluate the long-term efficacy and safety of paclitaxel- and sirolimus-eluting coronary stents among real-world patients and clinical situations.

Enoxaparin Beats Unfractionated Heparin as Adjunct Therapy for MI

New Therapy Significantly Reduces Risk of Repeat MI and Mortality

The ExTRACT-TIMI 25 (Enoxaparin and Thrombosis Reperfusion for Acute Myocardial Infarction Treatment - Thrombolysis in Myocardial Infarction) trial was a randomized, double-blind, double-dummy comparison of two anticoagulant strategies in more than 20,000 patients in 48 countries whose primary treatment for myocardial infarction (MI) was injection of fibrinolytic therapy. A new strategy using enoxaparin, a low-molecular-weight heparin, was used for the duration of the MI patient's hospitalization and was compared with the current strategy of unfractionated heparin for at least 48 hours. The TIMI Study Group determined which of the two strategies was more effective at preventing MI patients from either dying or having a second but nonfatal heart attack within one month after treatment. Both unfractionated heparin and enoxaparin inhibit thrombin. However, unfractionated heparin is delivered by intravenous infusion, while enoxaparin can simply be injected under the skin. Enoxaparin also appears to have more powerful anti-clotting effects by more effectively blocking the clotting mechanism at an earlier stage than unfractionated heparin. Researchers found that enoxaparin reduced the combined risk of death and MI within 30 days by 17 percent. Similarly, enoxaparin reduced the 30-day risk of nonfatal repeat MI by 33 percent, and the 30-day combined risk of death, nonfatal MI, and urgent need to re-establish blood flow to the heart by 19 percent. All of the findings were highly statistically significant. The trial enrolled 20,506 patients from 674 medical centers in 48 countries. All patients had ST-elevation MI (STEMI). They were treated with a fibrinolytic medication within six hours of first experiencing chest pain, and were then randomly assigned to receive therapy with enoxaparin or unfractionated heparin. To make sure there was no unintended bias in interpreting the results, the trial used a double-blind, double-dummy design: study participants received both intravenous infusions and twice-daily injections without the physician or the patient knowing which contained the study medication and which was the placebo. The rates of serious bleeding were lower overall than reported in prior trials. Patients who were treated with the enoxaparin strategy were more likely to experience major bleeding. However, when researchers calculated net clinical benefit, which takes into account both effectiveness and safety, the enoxaparin strategy was, on balance, associated with significantly better outcomes. The study has critical importance for the treatment of most patients who suffer an MI, said Elliott Antman, MD, Director, Samuel A. Levine Cardiac Unit at Brigham and Women's Hospital, Professor of Medicine, Harvard Medical School, and lead author of the ExTRACT-TIMI 25 study. Although percutaneous coronary intervention (PCI), has been shown to be an the most effective treatment for MI in specialized centers, the vast majority of patients worldwide receive clot-busting medications to treat their heart attack. The availability of PCI is still quite limited in most parts of the world, and even in large parts of the United States it is impossible to get a patient with acute MI to the catheterization laboratory in a timely fashion, said Dr. Antman. Fibrinolysis is the most common treatment for ST-elevation MI worldwide, and this study shows that the new strategy using enoxaparin is clearly preferable for enhancing that form of treatment for STEMI patients. The research was supported by a grant from Sanofi-Aventis.

Adult Stem Cells Improve Cardiac Function and Blood Flow in Patients with Heart Disease, New Study Finds

Noga® Cardiac Navigation System from Biologics Delivery Systems Group, Cordis Corporation, Helped Researchers Deliver Stem Cells to the Heart

Bone marrow-derived adult stem cells administered within the heart (intramyocardial) and coronary artery (intracoronary) tissues of heart disease patients improved patients’ heart function and blood flow, according to a pilot study presented during a poster session at the 2006 American College of Cardiology Scientific Session. The study also found that patients who received more stem cells experienced a higher degree of cardiac improvement. The results of this adult stem cell study are encouraging news for patients who suffer from serious coronary heart disease but additional clinical investigation is necessary to confirm these findings, said Mariann Gyangyasi, MD, Division of Cardiology, University of Vienna Medical Center, Vienna, Austria. This study is an important step forward in understanding the potential role of adult stem cells in patients with ischemic heart disease. Six months post-stem cell injection, patients had improved function at the target study site of the left heart ventricle. Improvements included a 4.7 percent increase in the strength of the patient’s ejection fraction (EF) (34.8±7.9 percent to 39.5±6.7 percent; p=0.015) and an increase in the movement of the inner heart wall during contraction (linear local shortening or LLS) (5.14±2.90 percent to 6.21±1.66 percent; p=0.035). Additionally, study participants experienced a 4.9 percent decrease in perfusion defects after receiving a stress-inducing drug (37.0±10.3 percent to 32.1±13.3 percent; p=0.088). The study examined 17 patients who were considered unsuitable candidates for conventional treatments such as coronary artery stenting or bypass surgery. Utilizing the investigational Myostar Injection Catheter, researchers administered bone marrow-derived stem cells into patients’ left heart ventricle, relying on the Noga® System to help them accurately identify the target injection site. The Noga System created highly precise, three-dimensional images of the heart. These images gave us a clear ‘map’ that helped us to successfully deliver the adult stem cells where we intended them to go, commented Dr. Gyangyasi. This imaging technology was critical to making this study possible. A secondary study finding was that patients experienced higher degrees of cardiac improvement as the number of stem cells administered within the myocardial and coronary tissues increased. This was documented through follow-up measures, including EF (p=0.01, r=0.709), LLS (pARRIVE II Registry Demonstrates Low 2.5 Percent TAXUS-Related Re-Intervention Rate in Complex Lesions

Six-month results are consistent with ARRIVE I data

Boston Scientific Corporation announced preliminary six-month results from its ARRIVE II registry, confirming the safety of the Taxus® Express2 coronary stent system in real-world patients. ARRIVE II expands on the ARRIVE I registry by studying more than 5,000 consecutively enrolled patients across 53 sites in the U.S., including patients with complex lesions (65 percent), multiple stents (38 percent) and diabetes (32 percent). The Company made the announcement at the i2 Summit held in conjunction with the annual American College of Cardiology Scientific Session in Atlanta. The ARRIVE II six-month data is very impressive, especially in light of the high percentage of complex lesions and patients, said John M. Lasala, MD, PhD, of Barnes-Jewish Hospital and Washington University School of Medicine in St. Louis, and the study’s Co-Principal Investigator. The diabetic subset data is particularly notable, showing lower re-intervention rates than the study's broader patient population. The results are very consistent with six-month data from ARRIVE I, further supporting the outstanding performance of the Taxus stent system in challenging lesions and high-risk patients. The ARRIVE II registry completed enrollment in October 2005 with a total of 5,007 patients. Preliminary clinical findings were collected for the first 4,057 patients (81 percent) enrolled through May 2005. Complete six-month data on all patients will be available in May 2006. ARRIVE II six-month findings demonstrated an overall Taxus-related major cardiac event rate of 3.6 percent, including cardiac death (0.7 percent), myocardial infarction (1.2 percent), and Taxus-related re-intervention of the target vessel (2.5 percent). This compares favorably with six-month ARRIVE I results, which showed an excellent overall Taxus-related major cardiac event rate of 4.4 percent and a re-intervention rate of 3.1 percent. The ARRIVE II registry reported a low stent thrombosis rate of 1.1 percent, which is consistent with safety data from other DES registries. The diabetic sub-population analysis demonstrated positive results, showing an overall Taxus-related major cardiac event rate of 3.3 percent and a re-intervention rate of 1.9 percent. The consecutive enrollment design of ARRIVE II yielded a very diverse and high-risk patient population involving patients with acute myocardial infarction (13.5 percent), multi-vessel stenting (15 percent), stenting of grafts (6.4 percent), small vessels with RVD 20 mm (20.5 percent) and stenting of in-stent restenotic lesions (5.9 percent). The high percentage of community-based hospitals enlisted in the study also contributed to a wide range of physician experiences and hospital capabilities, which better reflect real-world conditions.

McKesson’s New Hemodynamic Monitoring System Offers Reporting Workflow Enhancements

McKesson expanded its comprehensive portfolio of cardiovascular image and information management solutions with the market debut of Horizon Cardiology Hemo, a new hemodynamic monitoring system that enables cardiologists to expedite patient charting and final reporting. By automating the recording and monitoring of a patient’s vital signs and data during a cardiac catheterization procedure, the new solution fully completes the patient chart. It also can complete up to 90% of the final report when integrated with Horizon Cardiology, McKesson’s cardiovascular image and information solution (CVIS). Other integration features include tracking of inventory and supplies for each patient procedure to support proper billing and supply chain management. McKesson demonstrated Horizon Cardiology Hemo, the latest release of Horizon Cardiology and other technology solutions designed to support cardiac care at the American College of Cardiology annual scientific session (ACC.06) in Atlanta. With the latest version of Horizon Cardiology, cardiologists gain workflow enhancements, including reporting functionality that automates most fields to reduce manual data entry, regardless of care setting. Cardiologists can view a real-time report preview with side-by-side display of the final report and images. The new Horizon Cardiology platform is based on .Net technology. Web-enabled procedure reporting for cath, echo and nuclear cardiology enables cardiologists to work seamlessly, whether over a local network or remotely. Other new features include secure digital signature, comprehensive hemodynamic monitoring and inventory management for improved billing control.
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